Senior Regulatory & Quality Lead / PRRC (MDR / ISO 13485) (m/f/d)

QUMEA builds radar-based, contactless patient monitoring. Our RADIQ sensor platform watches over patients without cameras and without anything worn on the body, giving care teams in hospitals and long-term care reliable information on mobility, immobility and, increasingly, vital signs. We are a Swiss MedTech company with a growing presence across DACH, the Nordics and the wider EU, and a subsidiary in Stockholm.
We treat regulatory as a deliberate strength, not an obstacle. We already have CE-marked medical device functionality in the market, with more regulated features on the way. That is exactly why we are hiring you.

The role in one sentence
You will own MDR at QUMEA end to end, act as our Person Responsible for Regulatory Compliance (PRRC) under MDR Article 15, build and run our ISO 13485 quality management system, connect it with information security (ISO 27001) and risk management, and, above all, make compliance actually happen across the whole company.
Why this role matters
We are building this deliberately and at pace. Our quality system is in place, and the next step is to weave it even more tightly into the daily way every team works. The documentation itself is manageable and increasingly tool- and AI-assisted. The real challenge, and the bulk of this job, is change management: getting every team, from sensor commissioning to engineering to sales, to work in a process-compliant way without losing the pace that makes us good.
We are lean, fast and AI-first. Above all, we are looking for someone who already uses AI to make their own work smoother and sharper, and who then combines that mindset with deep regulatory and quality experience. Leveraging AI cleverly and across the board is not a nice-to-have here, it is how the role gets done day to day.

• MDR (EU 2017/745) end to end. You are our internal authority on medical device regulation: classification, intended-use definition, technical documentation, registration, and the Notified Body relationship for current Class I functions and for QUMEA's move toward Class IIa Software-as-a-Medical-Device functions.
• PRRC accountability (MDR Article 15). You act as QUMEA's Person Responsible for Regulatory Compliance: ensuring conformity is checked before devices are released, keeping technical documentation and the declaration of conformity up to date, and overseeing that post-market surveillance, vigilance and reporting obligations are met.
• The ISO 13485 quality management system. You build, operate and evolve the QMS company-wide so it is scalable and audit-ready, and so it reflects how we actually work.
• Audits and CAPAs. You prepare and run internal and external audits, and you own the CAPA process.
• Cross-framework coherence. You connect ISO 13485 (quality), MDR (regulatory) and ISO 27001 (information security) onto one governance, document-control and risk backbone instead of separate silos, working closely with our CIO/PRRC.
• Risk management. You run risk management per ISO 14971 and embed it into how decisions get made and documented.
• Supplier and security-process governance. You own supplier qualification and the regulatory side of our security processes.
• Change management across the company. You design the processes, define who does what, and bring people along with hands-on guidance and clear one-pagers. This is the heart of the role.
• The compliance cadence. You set and run the recurring reviews (monthly, quarterly, annual) where the right people make and document the right decisions, and you are part of those leadership conversations.

What you will do, hands-on
This is not a strategy-only role. You will:

• Write and structure technical documentation yourself (design history, risk files, V&V records), and build the templates, checklists and automation so others can too.
• Drive verification and validation: planning, evidence collection and reporting.
• Own requirements engineering and traceability across software, algorithms and devices, translating MDR, IEC 62304 and ISO 14971 into concrete product and engineering requirements.
• Support the implementation and improvement of our software design lifecycle, including knowing exactly where in the development process documentation has to happen.
• Guide our clinical evaluation work (clinical evaluation planning, study-design support, evidence collection) together with our research and clinical partners.

If this sounds like your dream job, we'd love to hear from you! Apply now with your CV and relevant supporting documents.